Reference number
ϲʿ 14630:2005
ϲʿ 14630:2005
Non-active surgical implants — General requirements
Edition 2
2005-05
Retirada
ϲʿ 14630:2005
37619
Retirada (徱ó 2, 2005)

Resumen

ϲʿ 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses.

With regard to safety, ϲʿ 14630:2005 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.

Informaciones generales

  •  : Retirada
     : 2005-05
    : Retirada de la Norma Internacional [95.99]
  •  : 2
     : 13
  • ϲʿ/TC 150
    11.040.40 
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